Implantech Associates Inc
Ventura, CA, US
IMPLANTECH ASSOCIATES, INC. appears in FDA device records in Ventura, CA. FDA records list 41 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 2 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 41 510(k) clearances for Implantech Associates Inc between 1989 and 2020. The busiest year on record is 1991, with 9. The most recent is 2020, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1989 | 2 |
| 1990 | 8 |
| 1991 | 9 |
| 1992 | 3 |
| 1993 | 1 |
| 1994 | 3 |
| 1995 | 1 |
| 1996 | 2 |
| 1997 | 2 |
| 2000 | 1 |
| 2001 | 1 |
| 2002 | 1 |
| 2005 | 2 |
| 2007 | 1 |
| 2014 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K200610 | Customized Contour Implant | FWP | Substantially Equivalent | |
| K191130 | Customized Contour Implant | FWP | Substantially Equivalent | |
| K172389 | ePTFE-Coated Auricular Implant | FZD | Substantially Equivalent | |
| K141027 | 3D EPTFE; ANATOMICAL CHIN, CURVILINEAR CHIN, EXTENDED ANATOMICAL CHIN IMPLANT, SUBMALAR II IMPLANT, DORSAL COLUMELLA IMP | FWP | Substantially Equivalent | |
| K071470 | IMPLANTECH EPTFE SHEETING, MODEL EPTFE-XXX | FTL | Substantially Equivalent | |
| K052505 | CALF IMPLANT, MODEL EC17-X | MIB | Substantially Equivalent | |
| K052504 | GLUTEAL IMPLANT, MODELS RND 5-X, TRD 6-X | MIB | Substantially Equivalent | |
| K013732 | GELZONE | MDA | Substantially Equivalent | |
| K012419 | CONFORM SHEETING, MODEL IGEL | MDA | Substantially Equivalent | |
| K002886 | IMPLANTECH COMPOSITE FACIAL IMPLANTS (MALAR, CHIN, AND NASAL) | LZK | Substantially Equivalent | |
| K973502 | IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT | LZK | Substantially Equivalent | |
| K964846 | IMPLATECH RP MEDICAL GRADE SILICONE GEL SHEETING | MDA | Substantially Equivalent | |
| K962824 | IMPLANTECH JEJ PERI-PYRIFORM IMPLANT | FZE | Substantially Equivalent | |
| K962261 | IMPLANTECH WM NASAL-LABIAL IMPLANT | LZK | Substantially Equivalent | |
| K943988 | IMPLANTECH NASAL LABIAL IMPLANT | LZK | Substantially Equivalent | |
| K943644 | IMPLANTECH TEMPORAL IMPLANT | FWP | Substantially Equivalent - Subject to Tracking Reg. | |
| K941960 | IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II | FZE | Substantially Equivalent | |
| K942876 | IMPLANTECH DORSAL NASAL IMPLANT | FZE | Substantially Equivalent | |
| K925426 | RIZZO NASAL IMPLANT | FZE | Substantially Equivalent | |
| K921582 | FLOWERS MEDIAL MALAR IMPLANT | LZK | Substantially Equivalent | |
| K921581 | CHIN WAFER | FWP | Substantially Equivalent | |
| K921580 | BRINK PRE-MAXILLARY IMPLANT | FZE | Substantially Equivalent | |
| K914297 | K.D. CHIN IMPLANT | FWP | Substantially Equivalent | |
| K913761 | 3-D ACCUSCAN FACIAL IMPLANTS | FWP | Substantially Equivalent | |
| K911516 | HIGH PROFILE CHIN IMPLANT | FWP | Substantially Equivalent | |
| K911515 | EXTENDED MALAR IMPLANT | LZK | Substantially Equivalent | |
| K911514 | ARTICULATED CHIN IMPLANT | FWP | Substantially Equivalent | |
| K911513 | TRAPEZOIDAL MALAR IMPLANT | LZK | Substantially Equivalent | |
| K910655 | COMBINED MALAR IMPLANT | LZK | Substantially Equivalent | |
| K905268 | FLOWERS JOWL IMPLANT | FWP | Substantially Equivalent | |
| K905267 | FLOWERS CHIN IMPLANT | FWP | Substantially Equivalent | |
| K904657 | FLOWERS DORSAL COLUMELLA IMPLANT | FZE | Substantially Equivalent | |
| K904656 | FLOWERS NASAL IMPLANT | FZE | Substantially Equivalent | |
| K902941 | CURVILINEAR SILICONE CHIN IMPLANT | FWP | Substantially Equivalent | |
| K902827 | ANATOMICAL MANDIBULAR IMPLANT STYLE II | FWP | Substantially Equivalent | |
| K902826 | ANATOMICAL MANDIBULAR IMPLANT STYLE I | FWP | Substantially Equivalent | |
| K902825 | EXTENDED CHIN IMPLANT STYLE II | FWP | Substantially Equivalent | |
| K902824 | EXTENDED CHIN IMPLANT STYLE I | FWP | Substantially Equivalent | |
| K901662 | ANATOMICAL MALAR IMPLANT | LZK | Substantially Equivalent | |
| K895152 | BINDER SUBMALAR FACIAL IMPLANT II | LZK | Substantially Equivalent | |
| K894493 | BINDER SUBMALAR FACIAL IMPLANT | LZK | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2028924 | 1000142697 | IMPLANTECH ASSOCIATES, INC. | 6025 NICOLLE ST., SUITE B, Ventura, CA 93003 US | 2026 | and 8 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KGZAccessories, Catheter
- GCXApparatus, Suction, Operating-Room, Wall Vacuum Powered
- HSTApparatus, Traction, Non-Powered
- JOLCatheter And Tip, Suction
- MHWDressing, Compression
- MIBElastomer, Silicone Block
- MDAElastomer, Silicone, For Scar Management
- EMJElevator, Surgical, Dental
- LZKImplant, Malar
- MICImplant, Muscle, Pectoralis
- KKYMaterial, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
- FTLMesh, Surgical, Polymeric
- FWPProsthesis, Chin, Internal
- FZDProsthesis, Ear, Internal
- JAZProsthesis, Facial, Mandibular Implant
- FZEProsthesis, Nose, Internal
- KGSRetention Device, Suture
- FTYTape, Measuring, Rulers And Calipers
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1063-2014 | Gelzone Shoulder Sleeve, Catalog Number SLV634, Lot Number 852766. Product Usage: To be used where limb support and/or elevation is considered necessary. | Implantech initiated the voluntary recall of Gelzone Shoulder Sleever, SLV-634, Lot Number 852766 because it may not satisfy customer requirements for the robustness of the Velcro closure. | Class II | Terminated | |
| Z-2211-2013 | Device Name: Terino Square Chin-Style II-Medium; Catalog Number: TSCII-M. To augment or reconstruct underdeveloped or traumatized mandibular region. | Implantech initiated a voluntary recall of certain lots of Terino Square Chin-Style II-Medicum (Lot # 848488 and 850156), after determining that the devices from the lot numbers do not conform to the dimensional requirements for the TSCII-M. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain